Peripheral VertigoPhase 3BBPVOMSBAFHNCT05586763
Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo.
A Phase 3 study testing Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg) in people with Peripheral Vertigo, run by Oman Medical Speciality Board at 1 site in Oman.
Trial summary
Background: Vertigo as acute symptom seem to be one of most common presentation in ED, can be treated in ED with multiple medication . Objective: This study aimed to compare the therapeutic efficacy of metoclopramide, promethazine and prochloroperazine in patients presenting with signs and symptoms suggestive of acute… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vertigo
- What is being tested?
- Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteOman
- Study dates
- 1 Feb 2022to 30 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- □ Acute peripheral vertigo with nausea or vomiting (vas, visual analog scale >5) during their emergency department episode of care for which the attending physician recommending antiemetic, onset with in 3 days .
- Age( 18- 60).
Who cannot join
- • Age >60.
- Any organic brain disease (Clear central cause; "malignancy with brain metastasis".)
- History of epilepsy
- Pregnancy.
- Dementia, Parkinson's disease
- Abnormal vital signs
Show all 11Show fewer
- Any known drug allergy to the study drugs
- Undergoing chemotherapy or radiotherapy
- Mechanical bowel obstruction or perforation, gastrointestinal bleeding
- Inability to understand study explanation or outcome measures (any reason)
- Patients who refused to participate study.
Trial locations and contacts
1 site in 1 country.
Oman1 site, 1 recruiting
- Recruiting
Al Nahdha hospital, AFH and Sohar hospital
Muscat, 968
Suad AlBulushi, MD, +96899266722, suadbulushi@gmail.com
Kawther Al Rahbi, MD, +96899822278, Alrahbi79@gmail.com
About this study
Background: Vertigo as acute symptom seem to be one of most common presentation in ED, can be treated in ED with multiple medication . Objective: This study aimed to compare the therapeutic efficacy of metoclopramide, promethazine and prochloroperazine in patients presenting with signs and symptoms suggestive of acute peripheral vertigo to the ED . Methods: A 3-arm multi-center, randomized, triple-blind, controlled study comparing three treatments for acute vertigo in three medical centers : AlNahdha hospital Oman , Sohar Hospital Oman and AFH hospital Oman. Oman From February 2022 to August 2024.
Read the detailed description
- Background Vertigo is one of most ED visit symptoms, It can be due to central or peripheral cause. The most frequent three reasons for vertigo are acute peripheral vestibulopathy (vestibular neuritis, labyrinthitis), Meniere's disease, and benign paroxysmal positional vertigo (BPPV). Usually ED doctors started with Epley maneuver for relief of symptoms and then started with medication.
- Objective:
This study aimed to compare the therapeutic efficacy of metoclopramide, promethazine and prochloroperazine in patients presenting with signs and symptoms suggestive of acute peripheral vertigo to the ED .
- Research methods: This will be done by assessing the Best medication can be used to treat peripheral vertigo with least side effect through Randomized triple blinded analysis will use 3 medications. All medications will be saved in similar syringe with white paper cover and labeled as A,B, C .The treating EM Doctor will prescribe medication as anti-vertigo then one of covered medication will be randomly taken among 3 medication groups. Target population will be all patient in age group (18-60) years visiting the emergency department at Al Nahdha hospital, AFH and Sohar hospital who complain of peripheral vertigo after assessment and excluding central cause. Ethical approval will be applied for through the OMSB (Ministry of health ethical committee)
- Conditions
- Peripheral Vertigo
- Being tested
- Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)
- Keywords
- ED, vertigo, metoclopramide, promethazine, Prochlorperazine
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)Drug
Also called Metoclopramid ( 10mg), IM phenergan (25mg) , IM stemetil( 12.5mg)
Each patient with vertigo symptoms will be registered in vertigo list after written consent taken. The ED doctor will take one paper from the vertigo list box and will write the case there including patient ID, date, age and symptoms. Assessment (VAS \& EEV) will be done in the pre- medication 0 min, and at 60 mins posts anti-vertigo medication. The medication will be provided blindly through the pharmacy. Any possible medication side effect and any possible further work up done for patient will be involved in each paper as ED doctor will put a tick near each point. Score will be written in papers as per patient evaluation of their symptoms grade from 1-10. The need for rescue medication ( betahisten or ondansetron ) will be recorded in the paper or is need eply manuver. Principle investigator in each centre will be responsible to collect the papers for analysis by end of each weeks.
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramid | Active comparator | IM Metoclopramid 10mg Receives: Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg) |
| Promethazine | Active comparator | IM Promethazine 25mg Receives: Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg) |
| prochloraperazine | Active comparator | IM prochloraperazine 12.5mg Receives: Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication effectiveness in peripheral vertigo.
- Compare the effects of IM metoclopramide or IM promethazine or IM prochloroperazine in three randomizing groups in the treatment of peripheral Vertigo in emergency setting using Visual Analogue Scale taken from visual vertigo analogue scale/adapted from Longridge et al.,2002. (Nausea and vertigo scores as measured by Visual Analogue Scale that include patient assessmet of his symptoms in view of vertigo/ nausea/ vomiting)
Measured: 1hr
Secondary outcomes (1)
The need of rescue medication/ appearing of side effects.
The need for more rescue medications to relive the symptoms or for any appearing side effect at the time frame of assessment for vertigo symptom/ side effects like extrapyramidal side effect.
Measured: 0-1hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Feb 2022
- Primary completion28 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 3-arm multi-center, randomized, triple-blind, controlled study comparing three treatments for acute vertigo Arm I : IM Metoclopramid ( 10mg) Arm II : IM Promethazine (25mg) Arm III : IM prochloraperazine( 12.5mg)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Medical Speciality Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Asma Salim Abdullah Al Buraiki, Oman Medical Speciality Board
- Investigators
- Asma Al Buraiki, MD, Principal investigator, Oman Medical Speciality Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586763
- Sponsor's protocol ID
- Omsb1993
- Acronym
- BBPVOMSBAFH
- Status last verified
- Jun 2024
- First submitted
- 12 Oct 2022
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo.
- ClinicalTrials.gov ID
- NCT05586763
- Acronym / sponsor ID
- BBPVOMSBAFH / Omsb1993
- Conditions
- Peripheral Vertigo
- Keywords
- ED, vertigo, metoclopramide, promethazine, Prochlorperazine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Oman Medical Speciality BoardOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Vertigo as acute symptom seem to be one of most common presentation in ED, can be treated in ED with multiple medication . Objective: This study aimed to compare the therapeutic efficacy of metoclopramide, promethazine and prochloroperazine in patients presenting with signs and symptoms suggestive of acute peripheral vertigo to the ED . Methods: A 3-arm multi-center, randomized, triple-blind, controlled study comparing three treatments for acute vertigo in three medical centers : AlNahdha hospital Oman , Sohar Hospital Oman and AFH hospital Oman. Oman From February 2022 to August 2024.
Detailed description
- Background Vertigo is one of most ED visit symptoms, It can be due to central or peripheral cause. The most frequent three reasons for vertigo are acute peripheral vestibulopathy (vestibular neuritis, labyrinthitis), Meniere's disease, and benign paroxysmal positional vertigo (BPPV). Usually ED doctors started with Epley maneuver for relief of symptoms and then started with medication.
- Objective:
This study aimed to compare the therapeutic efficacy of metoclopramide, promethazine and prochloroperazine in patients presenting with signs and symptoms suggestive of acute peripheral vertigo to the ED .
- Research methods: This will be done by assessing the Best medication can be used to treat peripheral vertigo with least side effect through Randomized triple blinded analysis will use 3 medications. All medications will be saved in similar syringe with white paper cover and labeled as A,B, C .The treating EM Doctor will prescribe medication as anti-vertigo then one of covered medication will be randomly taken among 3 medication groups. Target population will be all patient in age group (18-60) years visiting the emergency department at Al Nahdha hospital, AFH and Sohar hospital who complain of peripheral vertigo after assessment and excluding central cause. Ethical approval will be applied for through the OMSB (Ministry of health ethical committee)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- A 3-arm multi-center, randomized, triple-blind, controlled study comparing three treatments for acute vertigo Arm I : IM Metoclopramid ( 10mg) Arm II : IM Promethazine (25mg) Arm III : IM prochloraperazine( 12.5mg)
| Arm | Type | Receives |
|---|---|---|
| Metoclopramid | Active comparator | Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)IM Metoclopramid 10mg |
| Promethazine | Active comparator | Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)IM Promethazine 25mg |
| prochloraperazine | Active comparator | Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)IM prochloraperazine 12.5mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- □ Acute peripheral vertigo with nausea or vomiting (vas, visual analog scale >5) during their emergency department episode of care for which the attending physician recommending antiemetic, onset with in 3 days .
Key exclusion criteria (11 listed)
- • Age >60.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)Also: Metoclopramid ( 10mg), IM phenergan (25mg) , IM stemetil( 12.5mg)Each patient with vertigo symptoms will be registered in vertigo list after written consent taken. The ED doctor will take one paper from the vertigo list box and will write the case there including patient ID, date, age and symptoms. Assessment (VAS \& EEV) will be done in the pre- medication 0 min, and at 60 mins posts anti-vertigo medication. The medication will be provided blindly through the pharmacy. Any possible medication side effect and any possible further work up done for patient will be involved in each paper as ED doctor will put a tick near each point. Score will be written in papers as per patient evaluation of their symptoms grade from 1-10. The need for rescue medication ( betahisten or ondansetron ) will be recorded in the paper or is need eply manuver. Principle investigator in each centre will be responsible to collect the papers for analysis by end of each weeks. | Drug | Metoclopramid, Promethazine, prochloraperazine |
Primary outcome
medication effectiveness in peripheral vertigo.
Time frame: 1hr
1. Compare the effects of IM metoclopramide or IM promethazine or IM prochloroperazine in three randomizing groups in the treatment of peripheral Vertigo in emergency setting using Visual Analogue Scale taken from visual vertigo analogue scale/adapted from Longridge et al.,2002. (Nausea and vertigo scores as measured by Visual Analogue Scale that include patient assessmet of his symptoms in view of vertigo/ nausea/ vomiting)
1 secondary outcome
The need of rescue medication/ appearing of side effects.
Time frame: 0-1hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma Al Buraiki, MD principal investigator
Oman Medical Speciality Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg) in people with Peripheral Vertigo, run by Oman Medical Speciality Board at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asma Al Buraiki, MD (+96896735469, asma.b19@resident.omsb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication effectiveness in peripheral vertigo. (time frame: 1hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.